LONDON – The European campaign for every clinical trial to be published is coming to the U.S., with the Alltrials movement, co-founded by Bad Pharma author Ben Goldacre, signing up 50 patients' and medical organizations to the cause.

The U.S. launch came a week after Alltrials significantly widened the scope of its European support, attracting 85 pension fund and asset managers representing more than €3.5 trillion (US$3.83 trillion) in assets to its campaign.

Alltrials said the U.S. organizations supporting the cause represent 500,000 doctors, patients and researchers in the U.S. They are adding their names to a campaign that has the backing of more than 500 bodies in Europe.

U.S. signatories include the Society for Clinical Trials, the American College of Obstetricians and Gynaecologists, the American College of Physicians and Boston University School of Public Health. The Society for Clinical Trials said it was signing up because every study participant deserves data they contribute to yield the maximum benefit. "In order to design the highest quality and most ethical clinical trials in the future, we need to learn from and incorporate all past experience," the society said.

Alltrials said it is bringing its campaign to the U.S. because changes to the culture and practice for reporting clinical studies need to be global to be successful. The campaign has high-profile and active backers in Europe, including the British Medical Journal, which is supporting Alltrials' principles in its publication policy, and Glaxosmithkline plc, the first big pharma company to sign up and to begin to address the demands in its own approach to data curation and access.

The group of European investor interests was brought together by BNP Paribas Investment Partners. Helena Fiestas, head of sustainability research at BNP Paribas, said it is essential that companies publish complete and accurate information on trial results, so that investment decisions can be fully informed.

"Alongside doctors and their patients, investors also risk being misled, given an average of around 30 percent of pharmaceutical company valuations directly relates to the results of phase III clinical trials," Fiestas said.

The 85 asset managers (of which 65 are UK local authority pension funds) have written to investee companies asking them to retrospectively register past and ongoing trials; to publish the methods and results; post a summary within a year of completion; and support independent researchers in getting access to anonymized patient-level data.

While there is no suggestion that the investors will withdraw support from companies that do not comply, it certainly increases the pressure to publish all trials, regardless of results. Peter van der Werf, of fund manager Robecosam, is asking all the pharma companies in which it invests to sign up to the Alltrials principles.

"By not being transparent, biopharmaceutical companies put their reputation at risk. We deem this to be a financially material factor," van der Werf said.

PUBLISHING UPON APPROVAL

The clamor for clinical trials transparency is gathering force as the EMA is in the thick of administrative preparations to put its policy of publishing clinical study reports upon product approval into effect.

The two main pharma bodies, the European Federation of Pharmaceutical industries and Associations and the Pharmaceutical Research and Manufacturers of America, have agreed to the publication of clinical study reports once a product is approved, though they have some reservations about the EMA's definition of commercial confidentiality and of how individual patient confidentiality will be respected.

While publication after product approvals now seems a given, there is resistance to the idea of publishing all trials within a year of their completion. One particular pocket of resistance is contract research organizations (CROs), which argue that phase I trials should be exempted from the requirement to be registered and published within one year of completing.

Last month, UK CRO Richmond Pharmacology, of London, which specializes in conducting early stage trials, took the UK National Research Authority (NRA) to court, saying the NRA was acting unlawfully in asserting there is a legal requirement to register all clinical trials. The judge found in favor of Richmond on that narrow point of law, but said while there is no strict legal requirement, the NRA is within its rights to check that researchers comply with ethical requirements to register clinical trials.

The European CRO Federation (Eucrof), of which Richmond is a member, said phase I studies of basic mechanisms and modes of action of new drugs generate commercially confidential information. Patients and healthy volunteers are not expected to gain any health benefit, and given that phase I data should only be published once the information becomes relevant to patients, and not one year after a trial completes, Eucrof said.

While at present, there is no legal obligation to register phase I trials, that will become a legal obligation under the EU Clinical Trials Regulation (CTR), which is expected to come into effect (and supersede the EMA's publication rules) in 2017.

The CTR (which is limited to trials carried out in the European Union) will require phase I studies to be registered on the World Health Organization's open access registry, and summary reports and lay summaries to be published within a year of completion.

Eucrof, which represents 300 CROs, said the risks outweigh the stated benefits to patients. With the same requirements not applying elsewhere, sponsors are likely to move phase I development out of Europe. That would be a self-defeating outcome, since the purpose of CTR is to boost clinical research in Europe by simplifying the rules, Eucrof noted.

As things stand, the EMA policy of publishing clinical study reports of all products submitted after January 2015 – as and if they are approved – implies the first such release will be sometime around the middle of 2016. Publication following approval is likely to be around 10 years or so since the phase I trials were carried out.